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September 8, 2003
There
could be additional upside with Tularik’s/NASDAQ:
TLRK share price with the anticipation of clinical updates
on four of its drugs in the fourth quarter of 2003 and the first
half of 2004.
Tularik’s
clinical development is on track to enroll the first 100 patients
for a total of 750 total worldwide for T67 for liver cancer in a
pivotal trial by year-end. The company will give an enrollment
update by year-end and expects to present interim safety/efficacy
data in mid-2004. The primary endpoint is survival and surrogate
endpoints response rate, time to progression, and reduction in
alpha-fetal protein, and quality of life will also be monitored.
Currently there are no approved drugs for liver cancer, therefore
Tularik may seek accelerated approval for T67 if the drug shows
significant benefit based on surrogate endpoints from the first
100 patients.
In
July, the company initiated Phase II trials for T607 for liver
cancer, ovarian cancer, gastric cancer, and esophageal cancer. The
endpoint for each of the T607 trials is radiological response
rate. By the end of 2003, Phase II trials should be completed and
the results presented possibly at ASCO 2004.
On
January 24, 2003, Tularik initiated a multiple dose Phase I trial
in healthy individuals in the United Kingdom of T131,
a potent and orally active insulin sensitizer for the
potential treatment of Type II diabetes. If results are positive,
a Phase II trial could be initiated as early as the fourth quarter
of 2003.
Finally,
Tularik completed the single dose portion of the T487 Phase I
trial in healthy patients and has recently initiated the multiple
dose portion of the study. The company expects to initiate
proof-of-concept Phase II trials in rheumatoid arthritis and
psoriasis patients in the fourth quarter of 2003.
With
four drugs in clinical development and barring any unforeseen
events, Tularik is sure to bring at least one drug to market,
which will improve the company’s revenue stream and bring a
smile to investors faces.
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